Based on evidence-based medicine (EBM) and from the viewpoint of providing scientific evidence for clinical application, we found that Traditional Chinese Medicine (TCM) was short of adequate evidence to support its therapeutic effects due to lack of high quality clinical research. Data management plays a very important role in clinical research. Lack of adequate data management may lead to low quality clinical research. Thus, it is of great importance to establish a set of standards for data management so as to improve the quality of clinical research. Based on the real practice in Myocardial Infarction Secondary Prevention Study in TCM (MISPS-TCM), this article introduces methods on data audit in clinical trials of TCM.
Citation： ZHANG Junhua,DAI Guohua,SHANG Hongcai,CAO Hongbo,REN Ming,XIANG Yaozu,GAO Xiumei,ZHANG Boli. Data Audit in Large Scale Clinical Trial of Traditional Chinese Medicine. Chinese Journal of Evidence-Based Medicine, 2007, 07(3): 230-232. doi: Copy